Duns Number:960091929
Device Description: Vitale Hydrogel Dressing, 4"x4", 1/pouch, 10/box, 10 boxes/case
Catalog Number
23844
Brand Name
Vitale
Version/Model Number
23844
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAE
Product Code Name
Dressing,Wound,Hydrogel W/Out Drug And/Or Biologic
Public Device Record Key
6435e368-7a8a-40c0-a18a-20f252016702
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
April 13, 2017
Package DI Number
B492238441
Quantity per Package
10
Contains DI Package
B492238440
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 10 |